COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

Phase 3

Completed

Interventions: Drug: LCZ696
Drug: Enalapril matching placebo
Drug: LCZ696 matching placebo
Drug: Enalapril

Brief Summary: The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.

Detailed Description: The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.

Recruitment & Eligibility

Inclusion Criteria

Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF < 40%)
Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
Patients must be literate in German

Key

Exclusion Criteria

History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
Previous history of intolerance to recommended target doses of ACEIs or ARBs
Known history of angioedema
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
Symptomatic hypotension
Impaired renal function
Penile anatomical defects and Peyronie's disease
Diabetes mellitus Type I or insulin-dependent Type II
Known prostate cancer

Arm && Interventions

Group	Intervention	Description
LCZ696	LCZ696 matching placebo	LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
LCZ696	LCZ696	LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
Enalapril	Enalapril matching placebo	Enalapril 10 mg
Enalapril	Enalapril	Enalapril 10 mg

Primary Outcome Measures

Name	Time	Method
Erectile Function Score Using Index of Erectile Function (IIEF-15)	Week 12 (3 months)	The International Index of Erectile Function (IIEF-15) was used to assess erectile function in male patients with chronic heart failure. The IIEF-15 is a patient self-reported assessment of erectile dysfunction (ED) and consists of 15 questions assessing different aspects associated with ED. The domain evaluating erectile function consists of items 1, 2, 3, 4, 5 \& 15 and its total score was used here. Total score range =1-30. Items 1-5 is 6-point Likert-type scale from '0' (= No sexual activity), '1' (=Almost never or never) to '5' (= Almost always or always). Items 15 is 5-point Likert-type scale from '1' (= very low) to '5 '(= very high). Higher score indicates better outcome

Secondary Outcome Measures

Name	Time	Method
Summary of Change From Baseline in NT-proBNP Levels	Baseline, Week 4, Week 12	Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week	Baseline, Week 4, Week 12	Assessment of early-onset effect and end of study effect, regarding improvement in sexual activity, using patient's self-reported frequency of sexual activity per week. Patient was asked to complete a diary assessing sexual activity on a weekly basis